Capintec Inc recalls Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by…

Recall date

March 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1564-2020

FDA classification

Class II

Brand / firm

Capintec Inc

Sold / distributed

Worldwide distribution. US Nationwide, Australia, Austria, Bangladesh, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Hong Kong, India, Israel, Italy, Korea, Malaysia, Pakistan, Philippines, Poland, Saudi Arabia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK, and Vietnam. (list up…

Why it was recalled

It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.